This application claims priority to U.S. Provisional Patent Application Ser. No. 60/716,561 filed Sep. 13, 2005, the entire contents of which are incorporated herein by reference.
Without limiting the scope of the invention, its background is described in connection with devices and methods for treatment of urinary incontinence, as an example. Incontinent persons often urinate or void in a diaper or clothing rather than in a toilet causing significant discomfort and distress to the person. Incontinence affects numerous men and women worldwide; however, it is more prevalent among postmenopausal women, e.g., 22-42% of the population. Additionally, it is estimated that 15% to 30% of noninstitutionalized persons over the age of 60 and more than 50% of persons over the age of 60, who reside in nursing homes suffer from urinary incontinence.
In woman, for example continence is maintained through the integrated normal function of pelvic floor muscles, fascial structures, nerves, supporting ligaments and the vagina. Although, theories differ (e.g., reduced muscular force, reduced muscular endurance, or reduced active and passive tone of the pelvic floor muscles) the normal functioning of pelvic floor tissues is common to these theories. Sources of urinary incontinence vary. The most common sources include stress incontinence, urge incontinence and overflow incontinence. Stress incontinence results when the pressure on the bladder exceeds the resistance in the urethra from movement, exercise, lifting, sneezing, coughing or laughing. Urge incontinence results unihibited contractions of the bladder and result in an abrupt and urgent need to urinate. Overflow incontinence results from the leakage of urine from the bladder when its maximal capacity is exceeded.
Currently there are numerous methods to treat incontinence. These methods can be divided into four categories: i) management apparatus, ii) behavioral modification, iii) pharmacologic treatment, and iv) surgical interventions. The management apparatus generally includes absorbent and/or catheter structures (e.g., a diaper-like structure) worn by a user to retain any urinary and/or fecal incontinence. They can also include plugs or barriers that obstruct the flow of urine through the urethra. This method is effective at hiding the results but does little to hide the embarrassment of the user. Behavioral modification (e.g., bladder re-training, Kegel exercises) has also been used treat incontinence by strengthen and retraining the pelvic floor muscles. In addition, there are a variety of associated devices and methods to aid in behavioral training, e.g., intravaginal, intra-anal devices. Incontinence is often treated with pharmacologic agents, but often results in drug-related side effects. Lastly, surgical treatments of incontinence often involve invasive procedures with risks of post-surgical failure, infections and complications.
The foregoing problems have been recognized for many years and while numerous solutions have been proposed, none of them adequately address all of the problems in a single device.